Annual Report Board for the authorisation of pesticides (CTB)

Transcription

1 Annual Report 2004 Board for the authorisation of pesticides (CTB)

2 Bijlage 5 Annual Report Board for the Authorisation of Pesticides (CTB) Introduction All pesticides that are used, traded or stocked in the Netherlands should first be authorised under the Pesticides Act, for which the CTB (Board for the Authorisation of Pesticides) is responsible. The CTB was on 1 January 2000 established as an independent administrative body (ZBO). The CTB takes decisions based on the policy of the four ministries involved: Agriculture, Nature and Food Quality (LNV), Health, Welfare and Sports (VWS), Housing, Physical Planning and Environment (VROM), and Social Affairs and Employment (SZW). The CTB prepares a work programme and a budget, and publishes an annual statement of accounts, quarterly reports, the work programme and an annual report. The Supervisory Board, set up by the controlling ministries, does finally decide whether the CTB carries out its tasks as required. Currently a new act is being prepared which intends to provide a modern legal framework for the authorisation of pesticides. 1 The substances that are present as active substance in products are evaluated in a European context. The products derived from these substances may only be placed on the market after the CTB has decided that the possible risks are acceptable. Pesticides not only include plant protection products but also biocides; these are, e.g., products for disinfestation (including cooling water and flush water for drilling), wood preservation and antifouling (to protect ships). CTB decisions may have far-reaching consequences, for manufacturers and users of products but also for public health and the environment. The CTB operates in an area with a high societal and political sensitivity and the CTB and its pesticides policy receive much media attention. The CTB is well aware of the fact that it is operating in an environment with large - and sometimes conflicting - interests, nationally as well as internationally. Mission and strategy CTBs key tasks are: decision-making about the authorisation of pesticides in the Netherlands; providing the Dutch input into the European evaluation process of substances that are applied in pesticides; advising the policy-making ministries about the pesticides authorisation policy in the Netherlands and Europe. These tasks are based on the principle that they are conducted in a legitimate and functional way and that the quality is high (regarding scientific contents as well as legal-procedural aspects). To carry this into effect, the CTB has formulated a number of characteristics that are guiding in setting up its organisation and shaping the work processes: expertise, reliability, transparency, customer-orientation (while maintaining independence), efficiency, pro-active action and societal acceptability. CTBs aim to belong to the top of the European authorisation bodies, together with the optimisation of the current national authorisation will be the main points of the strategy of the CTB for the years ahead.

3 2 The authorisation policy Besides national regulations regarding the authorisation of pesticides there are European regulations, i.e., the Plant Protection Directive (91/414/EEC) and the Biocides Directive (98/8/EC). These Directives have been implemented in the Pesticides Act in order to let the authorisation of pesticides in the Netherlands also take place on the basis of European regulations. This means that legislation is harmonised at European level. Determinative for the way in which pesticides are evaluated is the question whether it is a product on the basis of an existing substance 1 or a product on the basis of a new substance 2. Products based on existing substances are evaluated according to a re-evaluation programme. As long as the EU has not yet evaluated the substances from which these products have been derived, authorisation of these products and the corresponding substance evaluations will be carried out on the basis of national regulations. This means that a transitional situation exists for products based on existing substances. For plant protection products this will last until 2008 and for biocides until Products derived from new substances are evaluated as follows. Designated substances are first evaluated in EU context and in case of authorisation included in an Annex to the relevant EU Directive. Products derived from the substances included in this list can subsequently be authorized per country (if they meet the internationally applicable authorisation criteria). The CTB can ahead of the final decision by the EU about the admissibility of the new active substance(s) grant a provisional authorisation; products can then already be authorized for a maximum period of three years pending the European substance authorisation. Such a provisional authorisation does, however, require a full evaluation of the dossier. Products can also be authorised on the basis of mutual recognition. This means that products that are authorized in any country of the European Union must upon application also be authorised in other countries unless opposed by specific national conditions (such as differences in climatological conditions, cropping conditions, or soil conditions). Operating procedures of the CTB The application and authorisation process A pesticide must be authorised before use in the Netherlands, for which purpose an application for authorisation can be submitted to the CTB by means of an application form. This application form contains questions about the effectiveness and the physical-chemical properties of the pesticide and about its possible effects on the environment, on the person who applies the product, and on public health. An application form should, together with the research substantiating the answers to the questions, be submitted to the CTB. After receipt of the form, the CTB investigates whether the dossier is complete and whether the submitted studies meet the quality criteria. If the dossier is incomplete, the applicant is given the opportunity to correct the omission. An incomplete application will not be handled. The data are then summarised and (risk) evaluations are prepared. The results thereof are tested against the standards and criteria as laid down in rules and regulations. This testing is then presented to the Board, consisting of experts who all have been appointed in a private capacity and who meet once a month to take the decisions. The process described above (from the submission of an application to the decision about authorisation) takes a maximum of 18 months, assuming that a complete dossier has been submitted and that no supplementary questions need to be asked. An applicant can arrange that not all research he needs to submit 1.Substances that were, insofar as plant protection products are concerned, in the EU on the market before 25 July 1993 or, insofar as biocides are concerned, in the EU on the market before 14 May Substances that were, insofar as plant protection products are concerned, not yet on the market in the EU before 25 July 1993, or, insofar as biocides are concerned, not yet in the EU on the market before 14 May 2000.

4 must be repeated by making an agreement with other pesticides authorisation holders. After these have issued a declaration of no objection, the applicant can refer to the dossiers in question as submitted by those other authorisation holders. Objection and appeal Objections can be lodged against decisions of the CTB. The Advisory Commission for Objections, set up by the CTB, advises on the objections. The CTB can reconsider an earlier decision on the basis of the advice given by the Advisory Commission for Objections. If desired, one can make an appeal to the court or request an interim provision from the Court of Appeal on Trade and Industry. 3 Financing The key activity of the CTB is financed by applicants/authorisation holders; i.e., the pesticides industry. The other activities, including advice on policy, are financed by the ministries that are responsible for these policies. The CTB enters into annual price/performance agreements with the ministries involved highlights Main achievements With a view on the expected intensification of the European workload after 2004 the motto of the work plan 2004 was The Netherlands in order first and then full steam into Europe. If necessary priority for clearing the Netherlands backlog before energetically addressing the European evaluations with the available capacity. It can be established that a large part of the objective has been met. The performance on handling the Dutch applications was better than in 2003, despite a record inflow of new applications. Against a legal term of 46 weeks for handling an application to the first College consideration, in 2004 this term was 49 weeks for applications for authorisation of plant protection products and 53 weeks for biocide applications. The average handling period in 2003 was 57 weeks. The terms showed a decreasing trend over Operations in the fourth quarter were on average carried out within the legal terms. The analysis of the European activities shows more nuance. The European planning was less stringent in early 2004 while the European directions were sharpened later in Subsequently, a combination of external causes and a shortage of experienced evaluation capacity caused some delay. The evaluation capacity is meanwhile being increased. A further improvement of the performance for the national as well as the European activities is of great importance to the CTB. A fast and effective substance evaluation is also an important condition to qualify for European evaluation assignments of new substances. Evaluation capacity CTB In the course of 2004 it became clear that the CTB needed to follow a more pro-active recruitment policy in view of the fact that the recruitment of new members of staff required more time than foreseen. This meant that the planned evaluation capacity was only reached late in Then the settling in of new employees still requires the necessary time. This fact, together with the expected workload in 2005 and later, caused the Board to recruit more employees than foreseen when the work plan was drawn up. This extension was partly reached in the autumn of More employees will still be recruited in early The new employees are financed form the applicable tariffs and fees.

5 4 Regulations An important development in 2004 was the promise of the Minister of LNV to the Lower House of Parliament to present - in the near future - a new act for plant protection products as well as biocides in the near future. The CTB is involved in this development by participating in the project group. The appeals to the Court of Appeal on Trade and Industry (CBb) regarding the reprioritisation and the exemptions granted for solving bottlenecks are among the reasons for this decision. The CBb has for both types of appeal raised prejudicial questions about the agreement between national and European legislation. This year exemptions will still be granted in the usual way on the basis of recommendations by the CTB. Policy A start has been made with the cooperation with surrounding Member States regarding the reregistration of products derived from substances placed in the EU framework. Agreement about this has been reached during a number of meetings based on the understanding that in any case sections with a similar evaluation will not be conducted twice. Furthermore, a letter of the Minister of LNV provided clarity about the question for which aspects regarding environment and plant protection a deviating evaluation method must be followed for the Netherlands. These in particular are aspects regarding conditions that are specific for the Netherlands, with exception of the derivation of the MTR which has been based on national policy. The same clarity is expected soon for the other aspects and for the biocides. Finally, it can be reported that the draft of a new version of the Handleiding voor de Toelating van Bestrijdingsmiddelen (Manual for the Authorisation of Pesticides) has become available. Visit Supervisory Board In May the Supervisory Board visited the CTB. Following this, the audit service of the Ministry of VROM conducted an audit commissioned by the Supervisory Board. The conclusions of this audit have been discussed with CTBs management and generally give cause for satisfaction. The CTB is obliged to the audit commission for a number of valuable recommendations. The conclusions, however, are still provisional; the Supervisory Board has not yet formulated a definitive judgement on the basis of the results of the audit and a reaction to this by the CTB. The CTB is looking forward to the definitive conclusions. Operational processes The most important developments concern the start of the archive project and the initiation of the Kristal quality project. The first results of the archive project have resulted in an archive that is considerably easier to access. During the archive project it gradually became clear that not only the archive is concerned but the question which methods and techniques the CTB needs to use in the future to carry out its primary tasks. The Kristal quality project will be guiding in this. In 2004 the process owners have been designated who have taken the initiative to review and improve their processes. This has resulted in the improvement, clarification and establishment of a number of work processes. Due to the long-term illness of the planning coordinator there has been a lack of progress in the development of the planning function. This will be addressed in early Finances The normal operations over 2004 showed a positive result of The 2003 result was It can be concluded that CTBs tariffs are on average cost-effective.

6 This result caused a further improvement of CTBs level of assets. The fact, however, that the CTB cannot take out a company liability insurance, means that the CTB runs financial risks that may exceed its financial strength. An agreement about the liability allocation must still be reached with the ministries. It is intended to include a provision as basis for own assets and a contingency provision for claims in the new Act. 5.3 Decisions about authorisations Key data Table 1: Shows the key data regarding authorisations in 2004 Biocides Plant protection Totals Applications products Withdrawn by applicant Rejected by CTB Definitively taken out of procedure Authorisations New authorisations New derived authorisations New parallel authorisations Prolongation of authorisations based on non-designated substances (formerly a-substances) Prolongation of authorisations based on designated substances (formerly b- and/or c- substances) Termination of authorisations by the CTB Authorisations terminated upon request of the authorisation holder Amendment of authorisations Amendment of the labelling instructions Transfer/change of address authorisation holder Name change authorised product Totals Applications Table 2: Summarises the number of applications submitted in the past four years Applications for authorisation Applications for extension field of use Applications for change composition authorised product Applications for prolongation authorisation Applications for derived authorisation Applications for prolongation derived authorisation Applications for authorisation parallel import Applications for prolongation authorisation parallel import Totals Small change of the formulation and changes in the Statutory Use Instructions and/or Directions for Use upon request of the authorisation holder.

7 5.3.3 Authorised products Totals Table 3 presents -per year- the total number of active substances and authorised pesticides based on those substances. 6 Table 3: Authorised pesticides and active substances (reference date 31 December) products active substances Biocides Plant protection products Total a Authorisations of plant protection products based on substances that are new for the Netherlands 1-methylcyclopropene (SmartFresh, N) Permitted is only the use as product to prevent ethylene damage to apples and tulip bulbs in air-tight storage areas by means of a space treatment. azoxystrobin (Heritage, N) Permitted is only the use as fungicide in professionally maintained recreation grasses (greens, tees, fairways, sports fields, etc.). Beauveria bassiana (BotaniGard WP, N and BotaniGard vloeibaar, N) Permitted is only the use as insecticide applied by means of a crop treatment in the cultures under glass of: a. strawberries, b. aubergines, courgettes, cucumbers, melons and sweet peppers, and c. flower crops, tree nursery crops, and perennial plants. boscalid (Cantus, N) Permitted is only the use as fungicide by means of a crop treatment in the culture of tulip and lily. boscalid (new substance) and mancozeb (existing substance) (Nautilus, N) Permitted is only the use as fungicide by means a crop treatment in the culture of flower bulb and corm crops on the understanding that application on sandy soils, insofar as these are located in the flower bulb growing area, is not permitted. florasulam (new substance) and fluroxypyr (existing substance) (PRIMSTAR, N) Permitted is only the use as herbicide in the culture of winter wheat, winter barley, winter rye, triticale, winter oats and spelt. iodosulfuron-methyl-sodium and foramsulfuron (both new substances) (MaïsTer, N) Permitted is only the use as herbicide in the culture of forage maize and grain maize. iodosulfuron-methyl-sodium (Hussar, N)* Permitted is only the use as herbicide in the culture of winter wheat, winter rye, triticale and in grass seed culture. kresoxim-methyl (new substance) and mancozeb (existing substance) (KENBYO MZ, N) Permitted is only the use as fungicide by means of a plant protection product in the culture of: a) sown onions and second year onion sets, and b) flower bulb and corm crops on the understanding that application on sandy soils, insofar as these are located in the flower bulb growing area, is not permitted. metalaxyl-m (new substance) and mancozeb (existing substance) (Fubol Gold, N)* Permitted is only the use as fungicide: a) in the culture of ware and starch potatoes; b) in the culture of tree nursery crops, and c) in the outdoor culture of Helichrysum. pyraclostrobin (new substance) and epoxiconazole (existing substance) (Opera, N) Permitted is only the use as fungicide, applied by means of a crop treatment, in the culture of a) winter 2. The total does not correspond with the totals of the separate fields of use because the same active substance may occur in different fields of use.

8 wheat and spring wheat; b) winter barley and spring barley, and c) winter rye. pyraclostrobin (new substance), epoxiconazole (existing substance) and kresoxim-methyl (new substance) (Optimo, N) Permitted is only the use as fungicide, applied by means of a crop treatment, in the culture of a) winter wheat and spring wheat; b) winter barley and spring barley, and c) winter rye. pyraclostrobin and boscalid (both new substances) (Signum, N)* Permitted is only the use as fungicide in the culture of leek; carrot; headed cabbage, cauliflower, broccoli, Brussels sprouts and curly kale; strawberry outdoors. silverthiosulphate (Chrysal AVB, N)* Permitted is only the use as pre-treatment for ethylene-sensitive cut flowers after harvest. spinosad (TRACER, N) Permitted is only the use as insecticide in the covered culture of tomato, sweet pepper and hot pepper. spiromesifen (Oberon, N)* Permitted is only the use as acaricide and insecticide in the non-soilbound culture under glass of: a) flower crops; b) cucumber, courgette, melon, gourd, pumpkin and squash on the understanding that the product may at the day of harvest not be applied before harvest; and c) tomato, sweet pepper, aubergine and hot pepper, on the understanding that the product may on the day of harvest not be applied before harvest. trifloxystrobin (new substance) and cyproconazole (existing substance) (Sphere, N) Permitted is only the use as fungicide applied by means of a crop treatment, in the culture of winter wheat and spring wheat b Authorisations of plant protection products based on existing active substances for the Netherlands cyproconazole (existing substance) and trifloxystrobin (new substance) (Sphere, N) daminozide (ALAR 85 SG, N) difenoconazole (Score 10 WG, N) epoxiconazole (existing substance) and pyraclostrobin (new substance) (Opera, N) epoxiconazole (existing substance) pyraclostrobin (new substance) and kresoxim-methyl (new substance) (Optimo, N) ethofumesate (TRAMAT 500, N) ethoprophos (Mocap 20 GS, N)* fluazifop-p-butyl (Fusilade Max, N) fluroxypyr (existing substance) and florasulam (new substance) (PRIMSTAR, N) glyfosate (Envision, N; Roundup Max, N; Roundup Energy, N;Touchdown Quattro, N; Clear-up P, N; Glyfos Envision 120 g/l, N; Glyfos Envision 7.2 g/l, N) linuron (LINUREX 50 SC, N) mancozeb (existing substance) and boscalid (new substance) (Nautilus, N) mancozeb and dimethomorph (both existing substances) (ACROBAT DF, N)* mancozeb (existing substance) and kresoxim-methyl (new substance) (KENBYO MZ, N) mancozeb (existing substance) and metalaxyl-m (new substance) (Fubol Gold, N) Metarhizium anisopliae (BIO 1020, N)* quinoclamin (ASEPTA MOGETON, N)* a Authorisations of biocides based on substances that are new for the Netherlands zinc pyrithione (new substance) and copper(i)oxide (existing substance) (Intersmooth 460 SPC, N* and Intersmooth 360 SPC, N*) Permitted is only the use as anti-fouling paint on seagoing vessels that are used professionally or commercially as well as war ships, marine-assistance ships or ships that are used for the military task.

9 b Authorisations of biocides based on existing active substances for the Netherlands copper(i)oxide (existing substance) and zinc pyrithione (new substance) (Intersmooth 460 SPC, N* and Intersmooth 360 SPC, N*) diethyl-m-toluamide (Jaico Muggenmelk Stick, N and Ultra Thon Anti-insect, N) hydrogen peroxide (CoolerClean Spray, N) hydrogen peroxide (Bioxyl, N and Glyroxyl, N) propiconazole (SAFETRAY Pallox, N) a Extensions of plant protection products based on active substances that are new for the Netherlands azoxystrobin (Amistar, N) bifenazate (FLORAMITE 240 SC, N) ferri phosphate (Ferramol Ecostyle Slakkenkorrels, N) kresoxim-methyl (Stroby WG, N) trifloxystrobin (Flint, N)* b Extensions of plant protection products based on existing active substances for the Netherlands 2,4-D and MCPA (both existing substances) Antikiek, 6252 N) bupirimate (Nimrod Vloeibaar, 6834 N and NIMROD 250 EC, N) chlorfenvinphos (BIRLANE GRANULAAT, 3222 N) difenoconazole (Score 250 EC, N)* dimethoate (Danadim Progress, 9978 N) fluazinam (Ohayo, N) glyphosate (AGRICHEM GLYFOSAAT 2, N and Agrichem Glyfosaat B, N) imidacloprid (ADMIRE, N) mancozeb (BRABANT Mancozeb Flowable, N; DITHANE DG NewTec, N; DITHANE M-45 SPUITPOEDER, N; DITHANE VLOEIBAAR, 7537 N; LUXAN MANCOZEB 450 FC, N; LUXAN MANCOZEB VLOEIBAAR, N; PENNCOZEB DG, N; PENNCOZEB 80 WP, 8758 N; PENNFLUID, N; TRIDEX DG, N; VONDOZEB DG, N). (BRABANT Mancozeb Flowable, N) mancozeb and cymoxanil (CURZATE M, 8708 N; CYMOXANIL-M, N and TURBAT, N) maneb (DITHANE M-22 SPUITPOEDER, 4864 N; TRIMANGOL DG, N; and TRIMANGOL 80 WP, 5928 N) penconazole (Topaz 100 EC, 9364 N) pirimicarb (Pirimor, 5794 N) prochloraz and folpet (MIRAGE PLUS 570 SC, N)* pyrimethanil (Scala, N) Streptomycis griseoviridis (MYCOSTOP, N) tolclofos-methyl (Rizolex vloeibaar, N) triflumizole (ROCKET EC, N) triflusulfuron-methyl (SAFARI, N)* a Extensions of biocides base don active substances that are new for the Netherlands There have been no such extensions.

10 b Extensions of biocides based on existing active substances for the Netherlands didecyldimethylammoniumchloride (Bardac 22, 7086 N) didecyldimethylammoniumchloride (Bardac 22-90, 9644 N) glutaaraldehyde (UCARCIDE 50 Antimicrobial, N) Authorisations of plant protection products based on organisms of natural origin (GNOs) Four plant protection products of natural origin were authorised in These are the products MY- COSTOP, BIO 1020, BOTANIGARD WP and BOTANIGARD VLOEIBAAR Authorisations solving a bottleneck for the user Fifteen products/fields of use have been authorised in 2004 which solve a problem for the users of pesticides. See the substances/products marked with an * in section a upto and including b. All solved bottlenecks are bottlenecks in the agricultural sector. 5.4 Terminations/restrictions of authorisations Totals Table 4 shows the number of authorisations deleted upon request of the authorisation holder. Table 5 shows the number of authorisations terminated by the CTB. Table 4: Authorisations deleted upon request of the authorisation holder in Biocides Plant protection products totals Table 5: Termination of authorisations by the CTB in Biocides Plant protection products Totals Terminations/restrictions of authorisations In view of environmental risk: Restrictions: mancozeb metalaxyl-m Due to implementation Community Measure (EU): Restrictions: diquat dibromide linuron Terminations/withdrawals: amitraz 3 flutolanil streptomycine-sulphate 3. Certain fields of use of this substance have been exempted from withdrawal in view of European Regulations (Essential uses).